StatsLibs

Biostatistics: Statistical inputs for Study Design and Sample Size Calculations Statistical inputs for statistical section of the Protocol Randomization Generation Statistical Review of Case Report Forms (CRFs) with Protocol Preparation of Statistical Analysis Plan (SAP) & Mock Shell (TLF Shells) Statistical Report Writing for the study based on final SAP and TLF outputs Data Analysis Using SAS Programming: TLFs Programming Using SAS (Production & Validation) for Final Analysis to be included in CSR; TLFs Programming Using SAS (Production & Validation) for Interim Analysis; Senior Review of TLFs output which are generated for the study; Add hock Request Analysis for Reviewing the Study Data, if require during and/or after study; Data Standardization: Annotate the final CRF as per SDTM standard; Mapping of CDISC - SDTM Specification and ADaM Specification; CDISC - SDTM Datasets and ADaM Datasets; Creation of define.xml, define.pdf for SDTM, ADaM and SDRG, ADRG for SDTM for ADaM; Medical Writing: Start-up Phase: Investigator's Brochure (IB), Protocols and ICDs. Conduct Phase: Pre-Database Lock (DBL) narratives, Shell Clinical Study Report (CSR) with mock tables. Closure Phase: Post-Database Lock (DBL) narratives, Clinical Study Report (CSR) with appendices. Post-study Phase: eCTD modules. Medical & Scientific Writing Support for Diverse Document Types: Clinical Study Protocol and Related Documents: Clinical Study Protocols for Phase 0, I to IV studies. Amendments/Revisions for Clinical Study Protocols. Protocol Synopsis / Protocol design / Protocol Outline. Informed Consent Form (including Master ICF). Responses to Ethics Committees and Regulatory Agencies. Clinical Study Report and Related Documents: CSR body (full, abbreviated, synoptic) for Phase 0, I-IV studies. CSR Appendices. CSR Addendum/Erratum/Synopsis. Clinical Subject Narratives.